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Country Submission Specialist II, Romania Nr ref.: /JOBS.pl inVentiv Health -Transforming Promising Ideas into Commercial RealityJob Title: 13530 Country Submission Specialist II, RomaniaPrimary Function:A local specialist regarding regulatory Institutional Review Board (IRB) and Ethics Committee (ED) processes and documentation requirements for the start-up and conduct of clinical trials according to Good Clinical Practice and local regulations. A Study Start Up Specialist may be assigned to more than one project.Job Description: * Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation, and provide updates of local processes and requirements to the Regulatory Intelligence portal * Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions * Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable) * Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process * Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents * Complete review of essential documents following Essential Document Checklist QC * Arrange and review translations of relevant study documents * Provide regular local status updates to project lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems as required for assigned projects * Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements * Support other departments as necessary * Identify site issues during start-up process, resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues * Train and mentor other associates on local regulations and internal procedures * Complete assigned training programs and apply learning * Complete necessary administrative tasks * May perform other duties as assignedExperience Required: * Bachelor's Degree in life science, pharmacy, nursing or RN, or equivalent clinical research experience * Relevant experience in preparing EC and regulatory submissions * Good understanding of principles, concepts, practices and standards of clinical research. * Ability to learn and follow task specific procedures, be attentive to detail and place importance on accuracy of information * Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located * Occasional travel may be requiredIn return we will offer: * A competitive remuneration package with excellent benefits * A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization * The opportunity to work within a successful and rewarding environmentLocation: Romania, home or office based.We look forward to receiving your application!inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry deliver new drugs and therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) is made up of more than 14,000 employees who have the ability to service clients in more than 90 countries. We offer a differentiated set of solutions designed to improve client performance and accelerate the process of bringing products to market. For more information, visit inVentivHealth.com Kontakt:
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